Endothelial Progenitor Cells

NCT ID: NCT01686269

Last Updated: 2012-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

Brief Summary

Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has an impact on multiple and diverse disciplines, including cardiology (coronary restenosis), cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and transplant medicine (chronic allograft rejection in hearts and kidneys). [1] In marked contrast to the deleterious effects of smooth muscle progenitor cells on neointimal hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an important role in vascular repair and in the inhibition of neointimal hyperplasia. [2] Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to neovascularization. Satoshi et al. have demonstrated that lineage-committed EPCs and CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute ischemic event in humans. [3] Reduced levels of circulating EPCs independently predict atherosclerotic disease progression, thus supporting an important role for endogenous vascular repair to modulate the clinical course of coronary artery disease. [4] These observations prompt the hypothesis that circulating EPCs may provide an endogenous repair mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional endothelium perioperatively. Therefore, the investigators examined whether levels of circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery to establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

blood collecting

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age from 18 to 85 years
• signed written informed consent
• angiographically documented coronary artery disease and indicated for coronary artery bypass surgery

Exclusion Criteria

• clinical or biochemical evidence for the presence of concomitant inflammatory disease
• chronic renal insufficiency (serum creatinine > 1.4 mmol/L)
• impaired left ventricular ejection fraction (< 45%)
• autoimmune or malignant disease
• thrombocytopenia (< 100 000/L)
• anemia (hemoglobin < 8.5 g/dL)
• inability to understand the consent form
• previous coronary bypass surgery
• severe peripheral arterial occlusive disease or atrial fibrillation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Kuan-Ming Chiu, MD

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Locations

Far Eastern Memorial Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kuan-MIng Chiu, MD

Role: CONTACT

kmchius@yahoo.com.tw

886-2-89667000

Facility Contacts

Kuan-Ming Chiu, MD

Role: primary

kmchius@yahoo.com.tw

886-2-89667000

Other Identifiers

FEMH-95-C-018

Identifier Type: -

Identifier Source: org_study_id